The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8876–8900 of 22113

  • HighFDA (Devices)·Z-0766-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays

    Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Module Failure Risk

    BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.

    Product
    FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2025·2025-01-01

    RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall

    Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.

    Product
    RUMMELL, Medline Item No. ST006ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0155-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

    Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to N-nitroso-duloxetine impurity above recommended limits. Patients should contact their healthcare provider.

    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2025·2025-01-01

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.

    Product
    DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2025·2025-01-01

    Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination

    Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2025·2025-01-01

    Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals

    Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.

    Product
    ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0162-2025·2025-01-01

    Duloxetine antidepressant recall for chemical impurity above FDA limit

    Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2025·2025-01-01

    Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits

    Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.

    Product
    KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25077·2024-12-26

    Avalanche Transceivers Recalled for Battery Contact Failure Risk

    Black Diamond recalls 770 PIEPS Pro IPS Avalanche Transceivers due to battery contact failure that could prevent operation during emergencies. Units were sold from February through November 2024 for $530–$620.

    Product
    PIEPS Pro IPS Avalanche Transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25079·2024-12-26

    GIKPAL 12-Drawer Dressers Recalled for Tip-Over and Entrapment Hazards

    GIKPAL 12-Drawer Dressers are being recalled because they can tip over and trap children if not anchored to a wall. About 800 units were sold on Walmart.com; consumers should stop using them and contact ONME Direct for a refund.

    Product
    GIKPAL 12-Drawer Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0307-2025·2024-12-25

    Griffith Foods Breader Recalled for Potential Metal Contamination

    Griffith Foods Ltd is recalling Item 25293502 Adhesion Breader EX due to potential pieces of metal in the product. The recall affects approximately 25,903 pounds distributed across multiple states.

    Product
    Item 25293502, ADHESION BREADER EX, 50 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0286-2025·2024-12-25

    Food-Grade Salt Products Recalled for Foreign Material Contamination

    Compass Minerals America Inc. is recalling approximately 67 metric tons of food-grade salt products due to foreign material contamination. The voluntary recall affects products distributed in Massachusetts, Indiana, Wisconsin, and Canada.

    Product
    Bulk salt product shipped in 1 metric ton tote; 50lb bag Special Purity Granulated Food-Grade Salt with UPC 041582150158; 44lb bag sifto Hy Grade Food Grade Salt, Compass Minerals America Inc. 9900 West 109th Street Overland Park, KS 99219
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0710-2025·2024-12-25

    Medical imaging software recall for incorrect DICOM orientation labels

    Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.

    Product
    mint Lesion, Software Versions: 3.10.0 and 3.10.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0295-2025·2024-12-25

    Yoder's Cashew Crunch Hard Candy Recalled for Undeclared Milk Allergen

    Yoder's Cashew Crunch hard candy is being recalled for undeclared milk allergen. The product was distributed in Iowa and Georgia to retail and wholesale customers.

    Product
    Yoder's Cashew Crunch, hard candy shipped in bulk in clear plastic bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0308-2025·2024-12-25

    Bulk Food Ingredient Recalled for Potential Metal Contamination

    Griffith Foods Ltd recalls bulk food ingredient Item 16354301 due to potential metal contamination. Product was distributed to food service facilities in Illinois, New York, North Carolina, Wisconsin, Texas, Tennessee, and Georgia.

    Product
    Item 16354301, MAXI - 44067705 - MAXI KR BA BA 3040 EX, 55.115 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0294-2025·2024-12-25

    Yoder's Cashew Crunch hard candy recalled for undeclared milk allergen

    Yoder's Cashew Crunch hard candy contains undeclared milk allergen. Affected packages were distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, 14oz, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0698-2025·2024-12-25

    ET Tube Holder Recalled Due to Skin Pressure Defect Risk

    Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0688-2025·2024-12-25

    K-Systems G85 Mini Incubator May Exceed Desired Temperature

    CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.

    Product
    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0680-2025·2024-12-25

    Laser Atherectomy Catheter Recalled for Marker Band Detachment Risk

    Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.

    Product
    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-1
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Drugs)·D-0139-2025·2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0311-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps recalled for possible metal contamination

    Rise Baking Company is recalling L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps sold at Aldi stores in five states due to potential metal contamination. Affected products carry specific Julian date codes from 24 302 to 24 311.

    Product
    L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0292-2025·2024-12-25

    Whole Foods Organic Carrots & Celery Recalled Due to E. coli O121:H19 Contamination Risk

    F&S Fresh Foods is recalling Whole Foods Market Organic Carrots & Celery due to potential E. coli O121:H19 contamination. The affected products were distributed in AZ, CA, HI, ID, and NV.

    Product
    WHOLE FOODS MARKET, Organic Carrots & Celery, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0285-2025·2024-12-25

    Impossible Spicy Ground Sausage Recalled for Potential Metal Contamination

    Impossible Foods is recalling Impossible Spicy Ground Sausage due to potential metal pieces in the product. The recall affects 32,536 cases distributed nationwide with use-by dates between June 28, 2025 and January 28, 2026.

    Product
    Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0293-2025·2024-12-25

    Yoder's Cashew Crunch hard candy recalled for undeclared milk allergen

    Yoder's Cashew Crunch hard candy is being recalled due to undeclared milk allergen on the label. The product was distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, Wt. 7oz, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states